UPDATE: On February 5, 2015, Judge Michael H. Simon of the United States District Court for the District of Oregon ordered a permanent injunction against Oregon dietary supplement manufacturer James G. Cole, Inc., its president, James G. Cole, and its former general manager, Julie D. Graves, for repeatedly introducing unapproved new drugs, misbranded drugs, and adulterated dietary supplements into interstate commerce. The Court’s injunction order requires the defendants to stop manufacturing, promoting and distributing their products until they comply with current good manufacturing practice (cGMP) requirements for dietary supplements and remove all disease claims from their websites and product labeling. The defendants would only be able to resume operations after they retain an independent expert who reports to the FDA that the firm is in full compliance, and the FDA conducts an inspection to verify the defendants’ corrective actions. The United States filed a complaint and a summary judgment motion against the defendants for unlawfully marketing and distributing adulterated dietary supplements as drugs that have not been approved by the FDA for their claimed uses. The Court’s order comes after a January 23, 2015 hearing on the merits of the case. Please see the U.S. Department of Justice’s press release and Judge Simon’s opinion and order of preliminary injunction for more information.
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FDA takes enforcement action against Oregon dietary supplement manufacturer
Company distributed unapproved and adulterated products online
The U.S. Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, is seeking a permanent injunction against the dietary supplement manufacturer James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.
If granted, the injunction would stop the company, based in Hood River, Ore., from promoting and distributing its products until it complies with current good manufacturing practice (cGMP) requirements for dietary supplements and all disease claims are removed from its websites, product labels, and all other products and websites under Cole’s custody and control.
“This company has ignored the multiple warnings they have been issued by the FDA by continuing to make unsubstantiated drug claims about the products it sells and by failing to conform to the cGMP requirements for dietary supplements,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “We are taking this action to protect the public health.”
James G. Cole, Inc. has marketed products online, with some sites linking to the company’s Facebook page. Cole has claimed that the dietary supplement products treat serious medical conditions, such as cancer, heart disease, rheumatoid arthritis, autism, Alzheimer’s, fibromyalgia, and high cholesterol. Under federal law, products offered for such uses are considered to be drugs, in that they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.
The company’s dietary supplement products have been unlawfully marketed as drugs that have not been approved by the FDA for their claimed uses. The products include PCA, PCA-Rx, C-60, ACAI Resveratrol, Cytomune, Anavone, Liver Rescue, Probiotics, and several other products, which are marketed under the brand names Maxam Labs, Advanced Sports Nutrition, and Maxam Nutraceutics.
Additionally, during inspections of James G. Cole’s facility in 2012 and 2013, the FDA found that the company distributed dietary supplements that were not manufactured in accordance with the cGMP requirements for dietary supplements. For example, the company did not establish an identity specification for each component and did not conduct at least one appropriate test to verify the identity of a dietary ingredient.
The complaint was filed in the U.S. District Court for the District of Oregon, Portland Division.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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